FDA is in discussions with the White House Office of Management and Budget and congressional committees about gaining access to $85 million in sequestered industry fees, the agency's financial officials said, noting that the issue is starting to resonate on Capitol Hill.

House appropriators with jurisdiction over FDA debated reducing the impact of sequestration on the agency, as it has recently done for others, so that FDA could fulfill commitments it made to the drug and device industries during user fee negotiations last year.

The ranking Republican on the Senate appropriations subcommittee with jurisdiction over FDA raised the possibility of exempting agency user fees from sequester cuts during a hearing on Thursday (April 18), with FDA Commissioner Margaret Hamburg also expressing concern that sequestration of user fees could harm future negotiations with industry.

House Energy and Commerce members questioned FDA's top veterinary official and other experts about the connection between the use of animal antibiotics and growing antibiotic resistance in humans during a hearing on the reauthorization of pioneer and animal drug user fee programs.

The Obama administration is asking Congress to give FDA more funding to implement the new food safety law, finish upgrades of new laboratories and strengthen inspections in China, while also seeking savings in drug and device programs.

Industry groups are looking to free up medical product user fees that have been withheld from FDA due to sequestration and to exempt user fees from future budget cuts, changes sources said could happen in next year's spending bill but may not be likely this fiscal year.

Just last year, Congress and the Obama Administration came together on a bipartisan basis to reauthorize for the fourth time the very successful Prescription Drug User Fee program (PDUFA). Under this important legislation, companies seeking approval for their new cures and treatments pay user fees to the Food and Drug Administration (FDA) for the review of their therapies.

The Senate health committee Wednesday (March 20) by a voice vote cleared animal drug user fee legislation that mirrored the agreement negotiated between FDA and industry, clearing the way for floor consideration where animal antibiotics are expected to enter the debate.

Drug Risk Evaluation and Mitigation Strategies' inefficiencies highlighted recently by the HHS Office of Inspector General will help shape the dialogue at FDA's upcoming prescription drug stakeholder meetings, according to sources focused on the issue.

FDA plans to spend $700,000 this fiscal year to establish a cooperative agreement with Brookings Institution's Engelberg Center for Health Care Reform to conduct research, workshops and meetings related to Prescription Drug User Fee Act goals such as those for rare diseases, Risk Evaluation and Mitigation Strategies and patient-reported outcomes.

Implementation of the new generic drug user fee act is complicated by uncertainty over the budget and the looming cuts mandated by sequestration, according to FDA Commissioner Margaret Hamburg, who acknowledged at a recent meeting with generic drug industry executives that the agency was off to a slow start in reducing the backlog of abbreviated new drug applications.

The Obama administration is asking appropriators to include in upcoming funding legislation a provision allowing FDA to fully collect user fees associated with medical devices, generic drugs, biosimilars, animal drugs and tobacco products, according to a document obtained by Inside Health Policy that lists “anomalies” the White House Office of Management and Budget recently sent to lawmakers.

FDA officials said Friday (Sept. 21) they plan to start the generic drug user fee program regardless of the outcome of congressional efforts to allow fee collection, as the lack of an appropriations measure affects when -- not if -- the fees will be collected.

The pharmaceutical industry is concerned that the administration's inclusion of FDA user fees among programs to be hit by the upcoming budget sequestration could permanently divert the industry-paid funding away from FDA, the head of the drug industry's trade group said Thursday (Sept. 20), a view echoed by the Biotechnology Industry Organization.

The House passed by unanimous consent late Wednesday (Sept. 19) a measure that would allow FDA to collect all of the generic drug user fees authorized in the recently enacted FDA Safety and Innovation Act, but the bill does not address other user fees, including for medical devices and biosimilars.

Mandatory across-the-board government funding cuts might apply to FDA user fees and as a result lead to a bigger agency impact that initially thought, FDA funding advocates said in advance of an administration report set for release this week that will detail cuts to occur under the budget act's sequestration.

An agreement on a federal drug track and trace measure is not likely to come before the August recess as initially hoped, but discussions among stakeholders, lawmakers and FDA are ongoing and will likely continue in September, with negotiators now hoping to conclude talks by the end of the year, according to a key stakeholder group.

FDA is continuing to move forward in developing a national post-market medical device surveillance system by seeking outside help to craft a roadmap for development and maintenance of device registries, with the move coming as the agency also works to implement the Unique Device Identifier system to track devices.